TBTC Study 23A: Pharmacokinetics of Intermittent Isoniazid and Rifabutin in HIV-TB

This study has been completed.

Sponsor:

Collaborator:

Department of Veterans Affairs

Information provided by:

Centers for Disease Control and Prevention

ClinicalTrials.gov Identifier:

NCT00023348

First received: September 6, 2001

Last updated: September 9, 2005

Last verified: September 2005

History of Changes

Purpose

Primary Objectives:

1) To determine the proportion of patients with HIV-related tuberculosis who have abnormal pharmacokinetic parameters for isoniazid and rifabutin.

Secondary Objectives:

To determine risk factors for abnormal pharmacokinetic parameters for isoniazid and rifabutin.
To evaluate the correlation between pharmacokinetic parameters of isoniazid and rifabutin and the occurrence of toxicity attributed to antituberculous therapy.
To evaluate the correlation between pharmacokinetic parameters of isoniazid and rifabutin and the efficacy of TB therapy.
To define and correlate phenotypic INH acetylator status with the results of genotypic acetylator data obtained in the parent trial.

Condition	Intervention	Phase
HIV Infections Tuberculosis	Drug: Isoniazid Drug: Rifabutin	Phase 2 Phase 3


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	TBTC Study 23A: Pharmacokinetics of Intermittent Isoniazid and Rifabutin in USPHS Study 23: Treatment of HIV-Related Tuberculosis Using a Rifabutin-Based Regimen

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Tuberculosis

Drug Information available for: Isoniazid Rifabutin

Genetic and Rare Diseases Information Center resources: Tuberculosis

U.S. FDA Resources

Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:

To determine the proportion of patients with HIV-related tuberculosis who have abnormal pharmacokinetics of isoniazid and rifabutin.

Secondary Outcome Measures:

1) To determine risk factors for abnormal pharmacokinetics of isoniazid and rifabutin
2) To evaluate the correlation between pharmacokinetic parameters of isoniazid and rifabutin and the occurrence of toxicity attributed to antituberculous therapy.
3) To evaluate the correlation between pharmacokinetic parameters of isoniazid and rifabutin and the efficacy of TB therapy.
4) To define and correlate phenotypic INH acetylator status with the results of genotypic acetylator data obtained in the parent trial.


Estimated Enrollment:	150
Study Start Date:	July 1999
Estimated Study Completion Date:	November 2002

Detailed Description:

This study will seek to enroll every eligible patient enrolled in TBTC Study 23. Consenting patients will be asked to undergo measurements of isoniazid (if receiving), rifabutin and 25-OH desacetyl rifabutin levels at a time point in the study when steady state rifabutin levels are expected to have been achieved (at least two weeks following the start of rifabutin).

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion:

Patient enrolled in TBTC Study 23
Informed consent

Exclusion:

1. Severe anemia (Hct <25%)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00023348

Show 23 Study Locations

Sponsors and Collaborators

Centers for Disease Control and Prevention

Department of Veterans Affairs

Investigators


Principal Investigator:	Marc Weiner, MD	Audie L. Murphy VA Medical Center, San Antonio TX

More Information

Additional Information:

(Click here for more information about the Tuberculosis Trials Consortium (TBTC) This link exits the ClinicalTrials.gov site

Publications:

Weiner M, Benator D, Burman W, Peloquin CA, Khan A, Vernon A, Jones B, Silva-Trigo C, Zhao Z, Hodge T; Tuberculosis Trials Consortium. Association between acquired rifamycin resistance and the pharmacokinetics of rifabutin and isoniazid among patients with HIV and tuberculosis. Clin Infect Dis. 2005 May 15;40(10):1481-91. Epub 2005 Apr 14.


ClinicalTrials.gov Identifier:	NCT00023348 History of Changes
Other Study ID Numbers:	CDC-NCHSTP-2173, 23A
Study First Received:	September 6, 2001
Last Updated:	September 9, 2005
Health Authority:	United States: Federal Government United States: Food and Drug Administration

Keywords provided by Centers for Disease Control and Prevention:


Tuberculosis TB

Additional relevant MeSH terms:


Tuberculosis Actinomycetales Infections Bacterial Infections Gram-Positive Bacterial Infections Mycobacterium Infections Isoniazid Rifabutin Anti-Bacterial Agents Anti-Infective Agents	Antibiotics, Antitubercular Antimetabolites Antitubercular Agents Fatty Acid Synthesis Inhibitors Hypolipidemic Agents Lipid Regulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015

To Top